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Process Engineer III Job at Engineering & Maintenance at Sanofi

Location Westborough, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_75129384-0002JC
Process Engineer III-POS_75129384-0002JC


Description
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

DEPARTMENT DESCRIPTION:

The External Manufacturing Science and Technology (MSAT) group supports Sanofi specialty care products manufactured at Contract Manufacturing Organizations (CMO’s). The group is the keeper of the body of manufacturing process knowledge and ensures manufacturing operations stay aligned with the registered process at each CMO.

MSAT is responsible for:

Providing on-site technical support at the CMO as needed.


Supporting and leading process Technology Transfers into and from CMO sites.

Providing technical leadership in process‐related investigations.

Overseeing data management & monitoring/SPC review processes.

Developing strategy for process validation activities.

Identifying and implementing commercial process/product life cycle improvements and integration of new technologies when applicable.

The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.

POSITION OVERVIEW / KEY RESPONSIBILITIES:

The External Manufacturing MSAT group is seeking a qualified candidate to fill a cell culture manufacturing technical support role for its contract manufacturing organization (CMO). The individual will work with a cross-functional team (QA, Validation, Regulatory and Supply Chain) to establish and ensure an uninterrupted product supply for multiple key products manufactured at CMO’s. The position will be based on the Westborough campus and will require periodic travel to CMO facilities in the US and abroad.

Specific responsibilities include the following:

Provides technical support and guidance for the design, scale-up, optimization, monitoring, and/or operation of the established manufacturing process validated at the CMO.
Support transfer and validation of cell culture operations into CMO’s, including on-site support, verification of process PCE’s and metrics, and related development activities.
Track and trend key process inputs and yields to determine opportunities to improve process yields. Present data at quarterly business reviews.
Implementation of process improvement opportunities.
Ensure compliance to Sanofi Corporate standards and cGMPs.
Provide status updates to the CMO Operations team and the Product Managers and escalate issues when appropriate.
Serve as a Technical Operations contact with the CMO and internal groups for resolving issues and potential conflicts.
Provide on-site support at CMO’s. This includes resolution of manufacturing exceptions and implementation of approved CAPA.
Support regulatory submissions related to the CMO tech transfer and subsequent commercial operation.
Codify process knowledge relevant to the manufacturing processes employed at the CMO.

Qualifications
BASIC QUALIFICATIONS:

BS and 8 years of professional experience OR MS and 6 years of professional experience OR PhD and 2 years of professional experience with commercial cell culture in a cGMP manufacturing environment.

PREFERRED QUALIFICATIONS;

4-8 years experience in a manufacturing environment (cGMP) for mammalian cell culture with specific knowledge of key unit operations including media preparation, seed train, and bioreactor operation.
Ability to work independently in a CMO environment and to manage and support multiple projects.
Experience with process and product transfer activities. Participation in GAP analysis and FMEA risk assessments.
Demonstrated success with execution and close out of process improvement studies.
Working knowledge of US and EMA guidelines for bulk drug substance manufacturing and understanding of current regulatory expectations.
Excellent written and verbal skills and demonstrated ability to liaise between internal QC, regulatory, supply chain and manufacturing disciplines and CMO Contract Manufacturing and Quality functions.


SPECIAL WORKING CONDITIONS:

Domestic travel required.

LEAD COMPETENCES:

Act for change
Co-operate transversally
Commit to customers
Strive for results
Lead teams



Job : Engineering & Maintenance
Primary Location : United States-Massachusetts-Westborough


Job Posting : Feb 17, 2017, 1:12:01 AM

Job Type : Regular
Employee Status : Regular